Clinical trials: Patient Safety
Chronic Obstructive Pulmonary Disease (COPD)
Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise…
- Trial name
- NCT01471171
- Testing
- Aclidinium Bromide
- Where
- 14 sites in Germany, Spain and 1 more
- Volunteers
- 112 people
- Sponsor
- AstraZeneca
Tumor, Colorectal Cancer
NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)
Study 07-PIR-02 is a Phase 2 study designed to evaluate the safety and efficacy of NKTR-102 (PEG-irinotecan) for the treatment of patients with colorectal cancer (CRC).
- Trial name
- NCT00598975
- Testing
- NKTR-102 100 mg/m2, NKTR-102 125 mg/m2, Cetuximab
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- Nektar Therapeutics
Crohn's Disease, Inflammatory Bowel Disease
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
- Trial name
- NCT01009281
- Testing
- AIN457
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.
- Trial name
- NCT00636207
- Testing
- Montelukast
- Volunteers
- 46 people
- Sponsor
- Organon and Co
Hepatitis D, Chronic
A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.
- Trial name
- NCT02731131
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- Italy
- Volunteers
- 12 people
- Sponsor
- Hoffmann-La Roche
Age-related Cataract, Phacoemulsification
Study to Evaluate the Safety of the Viscoelastic Substance PRO-149, Compared to Healon® EndoCoat.
Pilot, controlled, parallel group, open, randomized clinical trial to evaluate the safety of the viscoelastic substance PRO-149 (sodium hyaluronate 3%) after trans-surgical administration as a device in performing…
- Trial name
- PRO-149 (NCT04702802)
- Testing
- Sodium hyaluronate 3%
- Where
- Mexico
- Volunteers
- 36 people
- Sponsor
- Laboratorios Sophia S.A de C.V.
Recurrent Colorectal Carcinoma, Progressive Colorectal Carcinoma
Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy.
- Trial name
- NCT00545545
- Testing
- Imprime PGG 2 mg/kg, Imprime PGG 4 mg/kg, Cetuximab
- Where
- 2 sites in Philippines
- Volunteers
- 32 people
- Sponsor
- HiberCell, Inc.
Graft Versus Host Disease, Recurrent Adult Acute Lymphoblastic Leukemia
Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
This randomized phase III trial is studying low-dose prednisone or methylprednisolone to see how well they work compared with standard-dose prednisone or methylprednisolone in treating patients with newly diagnosed acute…
- Trial name
- NCT00929695
- Testing
- prednisone, methylprednisolone, questionnaire administration
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- Fred Hutchinson Cancer Center
Hypertension
Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients
This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.
- Trial name
- NCT00734630
- Testing
- nebivolol
- Where
- 75 sites in United States
- Volunteers
- 491 people
- Sponsor
- Forest Laboratories
Alzheimer's Disease
Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.
The purpose of this study is to investigate the effect of the rapidly acting intranasal insulin derivative (glulisine) on memory and cognition in 12 patients suffering from mild-moderate Alzheimer's Disease (AD) using a…
- Trial name
- NCT01436045
- Testing
- Insulin glulisine, Saline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- HealthPartners Institute
Psoriasis
PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept
The purpose of this study is to test the safety and effectiveness of infliximab in patients with plaque psoriasis who have been receiving the drug etanercept for treatment of their plaque psoriasis for at least four months…
- Trial name
- NCT00527072
- Testing
- infliximab
- Volunteers
- 217 people
- Sponsor
- Centocor Ortho Biotech Services, L.L.C.
Vulvodynia
Dysport in Vulvodynia Phase II Study
This study is designed to define optimal doses of Dysport and evaluate its efficacy and safety compared with placebo for the treatment of vulvodynia.
- Trial name
- DYVINIA (NCT03598777)
- Testing
- Botulinum toxin type A
- Where
- 9 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Ipsen
HIV Infections
Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice
This Post Marketing Surveillance study will be performed as an open-label, prospective, non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected patients.
- Trial name
- NCT01524900
- Where
- 53 sites in Austria, Poland and 1 more
- Volunteers
- 398 people
- Sponsor
- Boehringer Ingelheim
Severe Hemophilia A
Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)
The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.
- Trial name
- NCT01341912
- Testing
- Human-cl rhFVIII
- Where
- 2 sites in United States, Bulgaria
- Volunteers
- 3 people
- Sponsor
- Octapharma
Locally Advanced or Metastatic Solid Tumor(s), Prostate Cancer
A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors
The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.
- Conditions
- Locally Advanced or Metastatic Solid Tumor(s), Prostate Cancer, Esophageal Cancer, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT04424641
- Testing
- GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4.
- Where
- 6 sites in United States, Denmark and 2 more
- Volunteers
- 48 people
- Sponsor
- Genmab
Acute Pain
A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain
Patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy may be enrolled in this open label safety study.
- Trial name
- ATHENA-1 (NCT02656875)
- Testing
- TRV130
- Where
- 10 sites in United States
- Volunteers
- 768 people
- Sponsor
- Trevena Inc.
Non-cystic Fibrosis Bronchiectasis
Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis
This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of…
- Trial name
- MAHALE (NCT05006573)
- Testing
- Benralizumab
- Where
- 48 sites in United States, Argentina and 14 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Psoriasis
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.
- Trial name
- NCT03535194
- Testing
- Mirikizumab, Secukinumab
- Where
- 178 sites in United States, Argentina and 14 more
- Volunteers
- 1,484 people
- Sponsor
- Eli Lilly and Company
Soft Tissue Sarcoma
Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.
- Trial name
- NCT00717522
- Testing
- Pomalidomide
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Celgene
Glioblastoma, Gliosarcoma
SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
This phase II trial studies the side effects and how well vaccine therapy works when given together with temozolomide in treating patients with newly diagnosed glioblastoma.
- Trial name
- NCT02455557
- Testing
- Laboratory Biomarker Analysis, Montanide ISA 51 VG, Sargramostim
- Where
- 5 sites in United States
- Volunteers
- 66 people
- Sponsor
- Roswell Park Cancer Institute
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